Forty-six patients with urothelial cancer were treated with a systemic chemotherapeutic regimen consisting of methotrexate, vinblastine, 4'-epirubicin and cisplatin (M-VEC) in conjunction with glycosylated recombinant human granulocyte colony stimulating factor (rhG-CSF); then 33 were evaluated for response. Complete response was observed in 7 patients (21%) and partial response in 13 (39%). As far as the toxic effects of this treatment are concerned, mucositis of a minimum grade and leukopenia greater than grade 3 occurred in 5% and 10% of the patients, respectively; there were no cases of nadir sepsis and drug-related death. Minor toxicity such as nausea vomiting occurred in 81% of patients, and no patient required either dose-reduction or a delay of more than 5 d before starting of the second cycle. Thus, it may be concluded that M-VEC chemotherapy combined with rhG-CSF is useful in the treatment of urothelial cancer, especially when used as a neoadjuvant.